The maker of the narcotic painkiller OxyContin and three executives pleaded guilty Thursday to making false claims about the drug's risk of addiction, a U.S. federal prosecutor and the company said.
Purdue Pharma LP pleaded guilty in a Virginia court to felony misbranding of OxyContin with the intent to defraud. The company's president, chief lawyer and former chief medical officer also pleaded guilty to charges of misbranding — a crime of mislabelling, fraudulently promoting or marketing a drug for an unapproved use.
"With its OxyContin, Purdue unleashed a highly abusable, addictive and potentially dangerous drug on an unsuspecting and unknowing public," U.S. Attorney John Brownlee said in a release.
"For these misrepresentations and crimes, Purdue and its executives have been brought to justice."
The Stamford, Conn.-based company andexecutives agreed to pay $634,515,475 US in fines.
The company promoted OxyContin as being less addictive and less likely to cause withdrawal symptoms than short-acting opioid painkillers because of OxyContin's time-release formulation. The U.S. Food and Drug Administration did not approve the claims.
According to a statement of fact filed in court, the company's market research showed general practitioners were concerned about OxyContin's potential for abuse.
The company responded bygivingits sales representatives false information about OxyContin'spotential for abuse to present to doctors, the statement said.
"Nearly six years and longer ago, some employees made, or told other employees to make, certain statements about OxyContin to some health-care professionals that were inconsistent with the FDA-approved prescribing information for OxyContin and the express warnings it contained about risks associated with the medicine," the company said in a release Thursday.
"The statements also violated written company policies requiring adherence to the prescribing information. We accept responsibility for those past misstatements and regret that they were made."
The company said it has changed internal tracking, compliance and monitoring systems to prevent a recurrence.
Prescriptions almost tripled in N.L.
The fines will go to state and federal law enforcement agencies, the U.S. government, Medicaid programs, Virginia's prescription monitoring agency and individuals who sued the company
In Canada, OxyContin falls under the federal government's Narcotic Control Act. Health Canada has said it is concerned about reports of widespread abuse of the drug, especially in Atlantic Canada.
In Newfoundland and Labrador, for instance, the provincial government commissioned a task force after policeand health officials complained of addictions and rampant use of OxyContin as a street drug.
The task force, which reported in 2004, found that prescriptions had almost tripled within three years. It recommended a number of measures, including tamper-proof prescription pads for physicians' offices, hiring addictions counsellors and changing the school curriculum to warn students about prescribed narcotics.